(105 days)
The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.
AURICAL HIT is designed for Hearing Instrument Testing and Coupler-Based Fitting. AURICAL HIT connects via USB to a computer running the OTOsuite software. With the OTOsuite HIT Module one can perform traditional hearing instrument testing according to either the ANSI or IEC test protocols, and obtain a consistent picture of every hearing instrument, regardless of manufacturer or type. With the OTOsuite PMM Module one can perform Probe Microphone Measurements in a coupler for pre-programming and pre-fitting hearing instruments without the client being present. It is easy to position hearing instruments on snap-on couplers inside the AURICAL HIT test chamber and it is easy to access the hearing instruments in the test chamber during test without disturbing the test setup. The battery pill types are recognized automatically, and the reference microphone ensures reliable positioning in the test chamber.
The document provided describes the Aurical HIT Type 1082, a hearing aid calibrator. The evaluation involved non-clinical performance testing against established standards, rather than studies involving human participants or complex AI algorithms. Therefore, many of the requested categories are not applicable.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Aurical HIT Type 1082) |
|---|---|---|
| Intended Use | Hearing Aid Testing | Hearing Aid Testing |
| Hearing-aid test-box characteristics (C/Tests) | OSPL90, Full on gain, Input/Output, Attack/Recovery time, Reference test gain, Frequency response, Equivalent input noise, Harmonic distortion, Battery current drain, TeleCoil | OSPL90 & HFA-OSPL90, Full on gain, Input/Output, Attack/Recovery time, Reference test gain, Frequency response, Equivalent input noise, Harmonic distortion, Battery current drain, TeleCoil |
| Test Level Range | 50 - 90 dB SPL | 40 - 100 dB SPL |
| Frequency Range | 125 Hz - 8 kHz | 125 - 10,000 Hz |
| Standards met for Hearing Instrument Testing | ANSI S3.22, IEC 60118-7 | ANSI S3.22: 2003, IEC 60118-7: 2005 |
| Electrical Safety Standard | IEC 60601-1, Class 1, Type B | IEC 61010-1 |
| EMC Standard | IEC 60601-2 | IEC 61326-1 |
| Power Supply | USB, and external power supply for elevated outputs | USB Max. 2.5 W |
| Communication Port | USB 2 | USB 2.0 |
| PC Minimum Requirements | CPU Minimum 1.4 GHz, 512MB RAM, 1GB HDD, Windows XP/Vista/7 | 1.5 GHz or higher CPU (2 GHz recommended), 512 MB RAM (1 GB recommended for XP, 1 GB/1.5 GB recommended for Vista/7), 2.5 GB free disk space, Windows® XP/Vista/7 |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "non-clinical performance testing of the device against the applicable parameters specified in the following standards: ANSI S3.22: 2003, and IEC 60118-7:2005." This indicates bench testing of the device's physical and functional characteristics.
- Test set sample size: Not applicable in the context of human data. The "sample" here refers to the device itself and its components undergoing tests according to industry standards.
- Data provenance: Not applicable. The data is generated from performance testing of the manufactured device in a controlled lab environment according to specified international standards. It is not from a clinical population or geographical region.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The "ground truth" for this device is defined by the objective performance parameters outlined in the referenced ANSI and IEC standards for hearing aid calibrators. There is no mention of expert consensus being used to establish these fundamental technical standards.
4. Adjudication Method for the Test Set:
Not applicable. As the testing involves objective measurement against established technical standards, adjudication by experts is not described or required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. The device is a hearing aid calibrator, a piece of diagnostic equipment, not an AI system designed to assist human "readers" (e.g., radiologists, pathologists). Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a hardware device with accompanying software for instrument control and data acquisition, not a standalone algorithm or AI. The performance tested is the device's ability to precisely measure and present acoustic/magnetic stimuli as per the established technical standards.
7. The Type of Ground Truth Used:
The ground truth used is based on technical specifications and performance requirements defined by international standards:
- ANSI S3.22: 2003 (American National Standard for Hearing Aid Characteristics)
- IEC 60118-7: 2005 (International Electrotechnical Commission standard for Hearing Aids - Part 7: Measurement of the performance characteristics of hearing aids for quality inspection purposes)
- IEC 61010-1 (Safety requirements for electrical equipment for measurement, control, and laboratory use)
- IEC 61326-1 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements)
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning system that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.